# K251957: Coaptium Connect with Tissium Light

- Pathway: 510(k) (Special)
- Applicant: Tissium SA
- Decided: Sep 8, 2025 after 75 days
- Product code: SFD (In Situ Polymerizing Peripheral Nerve Repair Device)
- Device class: 2
- Regulation: 21 CFR 882.5270
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN240066 (2025). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN240066: COAPTIUM Connect with TISSIUM LIGHT, Tissium SA (2025) Summary page 5.

## Indications for use
COAPTIUM® CONNECT with TISSIUM® LIGHT is indicated for the sutureless repair of peripheral nerve injuries not in continuity in which a gap closure ≤ 1 cm is present or can be achieved with flexion of the extremity.

Source page: https://510kreport.com/device/K251957
Methodology: https://510kreport.com/methodology